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NCT00877006 · ClinicalTrials.gov registry record · Phase 3
Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With R-CVP or R-CHOP in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL) - Referred to as the BRIGHT Study
A Phase 3 study of Mantle Cell Lymphoma and Non-Hodgkin's Lymphoma, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 447
- Enrollment target
- 20
- Study locations
NCT00877006: Completed Phase 3 study of Mantle Cell Lymphoma and Non-Hodgkin's Lymphoma, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT00877006 is a Phase 3 study of Mantle Cell Lymphoma and Non-Hodgkin's Lymphoma that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 447 participants, above the 100-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (347% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00877006, a Phase 3 study of Mantle Cell Lymphoma and Non-Hodgkin's Lymphoma, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 447 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the study is to compare the complete response (CR) rate of bendamustine and rituximab (BR) with that of standard treatment regimens of either rituximab, cyclophosphamide, vincristine, and prednisone (R-CVP) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with advanced, indolent non-Hodgkin's lymphoma (NHL) or mantle cell lymphoma (MCL).
Primary Outcome
CR=complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present pretherapy; protocol-specified positron emission tomography (PET) scan assessment criteria; (if the spleen and/or liver were enlarged on the basis of physical examination and/or anatomic imaging before treatment) the liver and/or spleen were considered normal size on physical examination and by anatomic imaging after therapy, with disappearance of all nodules related to lymphoma; (if
Conditions Studied
Interventions
- DRUG prednisone
- DRUG cyclophosphamide
- DRUG rituximab
- DRUG bendamustine
- DRUG vincristine
Study Locations (20)
California
- Teva Investigational Site 11 - Corona
- Teva Investigational Site 21 - Fountain Valley
- Teva Investigational Site 52 - Fountain Valley
- Teva Investigational Site 64 - Fullerton
- Teva Investigational Site 40 - Los Angeles
- Teva Investigational Site 53 - Los Angeles
- Teva Investigational Site 57 - San Diego
Florida
- Teva Investigational Site 58 - Fort Myers
- Teva Investigational Site 38 - Hollywood
- Teva Investigational Site 23 - Jacksonville
- Teva Investigational Site 65 - Lake Worth
- Teva Investigational Site 156 - Miami
Colorado
- Teva Investigational Site 15 - Aurora
- Teva Investigational Site 155 - Denver
- Teva Investigational Site 5 - Fort Collins
Connecticut
- Teva Investigational Site 70 - New Britain
- Teva Investigational Site 37 - Norwalk
- Teva Investigational Site 67 - Southington
Arizona
- Teva Investigational Site 165 - Tucson
Arkansas
- Teva Investigational Site 167 - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 447 participants |
| Start Date | 2009-04-30 |
| Est. Completion | 2012-03-31 |
| Phase | Phase 3 |
What the finished NCT00877006 record still lists
NCT00877006 is an interventional study that assigns participants to a tested intervention. The registered 447 participants enrollment target is mid-sized for trials with a published cap, above the 100-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (347% higher).
The record links to 2 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which prednisone is the first listed.
NCT00877006 names 20 study sites across 6 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT00877006 about?
NCT00877006 is a clinical study titled "Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With R-CVP or R-CHOP in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL) - Referred to as the BRIGHT Study". The primary objective of the study is to compare the complete response (CR) rate of bendamustine and rituximab (BR) with that of standard treatment regimens of either rituximab, cyclophosphamide, vincristine, and prednisone (R-CVP) or rituximab, cyclophosphamide, doxorubicin, vincristine, and predni...
What is the current status of trial NCT00877006?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 447 participants. The study started on 2009-04-30. Estimated completion is 2012-03-31.
What conditions does trial NCT00877006 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma.
What interventions are being tested in trial NCT00877006?
The interventions under investigation include: prednisone (DRUG), cyclophosphamide (DRUG), rituximab (DRUG), bendamustine (DRUG), vincristine (DRUG).
Who is sponsoring clinical trial NCT00877006?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00877006 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00877006's enrollment target sits among peer trials
447 6th of 102 higher than 97 of 102 other Mantle Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mantle Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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